A Prospective, Single-Center, Single-Arm Phase II Clinical Trial of Cryoablation Combined With Camrelizumab in the Treatment of Advanced or Unresectable Soft Tissue Sarcoma Refractory to Standard Therapy
The main purpose of this trial is to investigate and evaluate the efficacy of cryoablation combined with camrelizumab treatment to patients with advanced or inoperable soft tissue sarcomas after standard treatment failure.
• Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
• Age≥14 years old, and≤70 years old ;
• Pathologically diagnosed as soft tissue sarcomas, and staging for advanced or unresectable patients ;
• Patients with standard treatment (such as chemotherapy) failure ;
• No previous treatment with PD-1 antibody ; or those who have previously received PD-1 antibody therapy and progressed at least half a year later;
• According to the RECIST1.1 standard, there are ≥3 measurable lesions; the distribution sites of multiple lesions are in ≤3 organs (which may include the abdominopelvic cavity, extremities, liver, lungs, pleura, etc.); the size of the target lesions is 1.0 - 5.0 cm.
• ECOG score 0-1 ( see Appendix ) and expected survival time greater than 3 months ;
• Patients with brain metastasis who were stable for at least one month after treatment and who do not require the use of glucocorticoids can be included.
• echocardiography showed left ventricular ejection fraction ≥ 50 %;
⁃ The results of laboratory tests should meet at least the following indicators :
‣ （1）White blood cell count ≥ 3.0 × 109 / L; （2）absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ; （3）absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L; （4）platelet ( PLT ) ≥ 75 × 109 / L; （5）hemoglobin ≥ 10g / dL ( no blood transfusion in the past 7 days ) ; （6）Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; （7）partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; （8）serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min; （9）Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN or 5×ULN (for patients with liver metastases).; （10）Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN or 5×ULN (for patients with liver metastases).; （11）total bilirubin ( TBIL ) ≤ 1 × ULN 11. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment.
‣ 12\. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.